ASTM_F_2706_-_08_2014.pdf

Designation:F270608(Reapproved 2014)Standard Test Methods forOccipital-Cervical and Occipital-Cervical-Thoracic SpinalImplant Constructs in a Vertebrectomy Model1This standard is issued under the fixed designation F2706;the number immediately following the designation indicates the year oforiginal adoption or,in the case of revision,the year of last revision.A number in parentheses indicates the year of last reapproval.Asuperscript epsilon()indicates an editorial change since the last revision or reapproval.1.Scope1.1 These test methods cover the materials and methods forthe static and fatigue testing of occipital-cervical and occipital-cervical-thoracic spinal implant assemblies in a vertebrectomymodel.The test materials for most combinations of occipital-cervical and occipital-cervical-thoracic spinal implant compo-nents can be specific depending on the intended location andintended method of attachment.1.2 These test methods are intended to provide a basis forthe mechanical comparison among past,present,and futureoccipital-cervical and occipital-cervical-thoracic spinal im-plant assemblies.They allow comparison of occipital-cervicaland occipital-cervical-thoracic spinal implant constructs withdifferent methods of application to the spine.These testmethods are not intended to define levels of performance,sincesufficient knowledge is not available to predict the conse-quences of the use of a particular device.1.3 These test methods set out guidelines for load types andmethods of applying loads.Methods for three static load typesand two fatigue tests for the comparative evaluation ofoccipital-cervical and occipital-cervical-thoracic spinal im-plant assemblies are defined.1.4 These test methods establish guidelines for measuringdisplacements,determining the yield load,and evaluating thestiffness and strength of occipital-cervical or occipital-cervical-thoracic spinal implant assemblies.1.5 It may not be possible to test some occipital-cervical andsome occipital-cervical-thoracic spinal constructs in all testconfigurations.1.6 The values stated in SI units are to be regarded asstandard.No other units of measurement are included in thisstandard.1.7 This standard does not purport to address all of thesafety concerns,if any,associated with its use.It is theresponsibility of the user of this standard to establish appro-priate safety and health practices and determine the applica-bility of regulatory limitations prior to use.2.Referenced Documents2.1 ASTM Standards:2E4 Practices for Force Verification of Testing MachinesE6 Terminology Relating to Methods of Mechanical TestingE739 Practice for StatisticalAnalysis of Linear or LinearizedStress-Life(S-N)and Strain-Life(-N)Fatigue DataE1823 Terminology Relating to Fatigue and Fracture TestingF1582 Terminology Relating to Spinal ImplantsF1717 Test Methods for Spinal Implant Constructs in aVertebrectomy ModelF2077 Test Methods For Intervertebral Body Fusion Devices3.Terminology3.1 DefinitionsFor definitions of terms relating to thesetest methods,see Terminologies E6,F1582,and E1823.3.2 Definitions of Terms Specific to This Standard:3.2.1 active length of the longitudinal element,nthestraight line distance between the centers of rotation of the testblocks.3.2.2 block moment arm,nthe perpendicular to the ap-plied load between the insertion point of an anchor and the axisof the hinge pin.3.2.3 compressive or tensile bending stiffness(N/mm),nthe compressive or tensile bending yield force divided byelastic displacement(see the initial slope of line BC in Fig.1).3.2.4 compressive or tensile bending ultimate load(N),nthe maximum compressive or tensile force in the X-Z planeapplied to an occipital-cervical or occipital-cervical-thoracicspinal implant assembly(see the force at Point E in Fig.1).Theultimate load should be a function of the device and not of theload cell or testing machine.1These test methods are under the jurisdiction of ASTM Committee F04 onMedical and Surgical Materials and Devices and are the direct responsibility ofSubcommittee F04.25 on Spinal Devices.Current edition approved Oct.1,2014.Published November 2014.Originallyapproved in 2008.Last previous edition approved in 2008 as F2706-08.DOI:10.1520/F2706-08R14.2For referenced ASTM standards,visit the ASTM website,www.astm.org,orcontact ASTM Customer Service at serviceastm.org.For Annual Book of ASTMStandards volume information,refer to the standards Document Summary page onthe ASTM website.Copyright ASTM International,100 Barr Harbor Drive,PO Box C700,West Conshohocken,PA 19428-2959.United States1 3.2.5 compressive or tensile bending yield load(N),nthecompressive or tensile bending force in the X-Z plane neces-sary to produce a permanent deformation equal to 0.020 timesthe active length of the longitudinal element(see the force atPoint D in Fig.1).3.2.6 coordinate system/axes,nthree orthogonal axes aredefined in Figs.2 and 3.The anterior-posterior axis is X withpositive being anterior.The medial-lateral axis